Study Completed

Osteoarthritis

Bayer Identifier:

19649

ClinicalTrials.gov Identifier:

NCT03330288

EudraCT Number:

Not Available

EU CT Number:

Not Available

Prospective multicenter non-interventional study in patients with knee or hip osteoarthritis having a Theraflex treatment

Trial purpose

The main purpose of this study is to evaluate how a long-term treatment with Theraflex during 64 weeks affects pain intensity in the affected knee or hip joint, the activity in daily living, the quality of life and patient satisfaction with treatment.

Key Participants Requirements

Sex

All

Age

45 - 75 Years

Inclusion Criteria
- Patients 45 to 75 years with Hip or Knee OA stage I to III
- Patient started current treatment with Theraflex not more than 2 weeks prior to inclusion into the study
- Personally signed and dated informed consent
Exclusion Criteria
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Patients with Hip or Knee OA stage 0 or stage IV
- Patients who have both Hip and Knee OA and OA of any other location
- Contraindications for use of Theraflex in accordance with approved label(known hypersensitivity, severe chronic renal failure)
- Females who are pregnant or breastfeeding
- Patients who completed a treatment with Theraflex or another combination of Gl+ Ch less than 5 months before start of the current treatment
- Patients who completed intra-articular corticosteroids treatment in the last 3 months to exclusion criteria
- Patients who completed hyaluronic injections of the lower limbs in the last 6 months

Trial summary

Enrollment Goal

1110

Trial Dates

November 2017 - July 2020

Phase

Phase 4

Could I Receive a placebo

Products

Theraflex® (Glucosamine hydrochloride/Chondroitin sodium sulfate, BAY874017)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Recruiting	Many locations	Many locations, Russia
Completed	Sci-Res Institute of Rheumatology n.a. V.A. Nasonova of RAMS	Moscow, 115522, Russian Federation

Primary Outcome

Changes in quality of life assessed by Knee injury and Osteoarthritis Outcome Score (KOOS) in patients with knee OA
Changes in pain, other symptoms, functions and knee related quality of life assessment will all be collected by KOOS questionnaire
Time Frame:
Up to 64 weeks
Changes in quality of life assessed by Hip injury and Osteoarthritis Outcome Score (HOOS) in patients with hip OA
Changes in pain, others symptoms, functions and hip related quality of life assessment will all be collected by HOOS questionnaire
Time Frame:
Up to 64 weeks

Secondary Outcome

Drug utilization of Theraflex therapy
as reported by the patient to their physician
Time Frame:
Up to 64 weeks
Patient satisfaction measured with a Likert response scale
measured with a Likert response scale (from 1-very dissatisfied to 5 – very satisfied)
Time Frame:
Up to 64 weeks
Painkiller usage - type
Time Frame:
Up to 64 weeks
Painkiller usage - length
Time Frame:
Up to 64 weeks
Painkiller usage - frequency
Time Frame:
Up to 64 weeks
Other medical/physical therapy usage-type
Time Frame:
Up to 64 weeks
Other medical/physical therapy usage-frequency
Time Frame:
Up to 64 weeks
Other medical/physical therapy usage-length
Time Frame:
Up to 64 weeks

Trial design

Prospective multicenter non-interventional study in patients with knee or hip osteoarthritis having a Theraflex® treatment to evaluate changes in pain, functions in daily living, and quality of life for an observation period up to 64 weeks

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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